Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT06228118
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2024-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-28', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison results', 'timeFrame': '30minute', 'description': 'Compare the test results conducted by professionals using investigational device and the comparator, and the positive percent agreement (PPA=100%), negative percent agreement (NPA=100%) and overall percent agreement (OPA=100%) were calculated.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the usability and user comprehension of investigational device', 'timeFrame': '30minute', 'description': 'The accuracy rate of the critical task is 100%. The Overall Percent Agreement for investigational device is 100% when conducted by a lay user. The accuracy rate of the each questions in the Knowledge assessment is 100%, and 100% of the Ease of operation assessment chose normal, easy, or very easy.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Pregnancy']}, 'descriptionModule': {'briefSummary': 'This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.\n\nLay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay User Study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Method comparison study exclusion criteria\n\n * Female；\n * 18-55 years of age；\n * Voluntary and sign informed consent form.\n2. Lay user study inclusion criteria\n\n * Female；\n * 18-55 years of age；\n * Voluntary and sign informed consent form；\n * Willingness to perform self-test of investigational device；\n * Have the ability to read English.\n\nExclusion Criteria:\n\n1. Method comparison study exclusion criteria\n\n * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；\n * Within 8 weeks of childbirth or abortion；\n * The investigator has reason to believe that it is inappropriate for subjects to participate in the study.\n2. Lay user study inclusion criteria\n\n * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；\n * Within 8 weeks of childbirth or abortion；\n * The investigator has reason to believe that it is inappropriate for subjects to participate in the study；\n * Background in a medical or laboratory testing.'}, 'identificationModule': {'nctId': 'NCT06228118', 'briefTitle': 'Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Andon Health Co., Ltd'}, 'officialTitle': 'Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System', 'orgStudyIdInfo': {'id': 'IHC-3000-LCFA01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects enrolled in method comparison study only'}, {'label': 'Subjects enrolled in both the method comparison study and lay user study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'First Teaching hospital of Tianjin University of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andon Health Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}